Summary: Visceral Leishmaniasis (VL) is particularly challenging to treat in patients coinfected with human immunodeficiency virus (HIV). Antimonial drugs used in first-line treatments in eastern Africa are more toxic in immunocompromised patients. This trial was designed to assess the efficacy and safety of both the currently internationally recommended treatment of AmBisome® (30 mg/kg) monotherapy and the new AmBisome® (40 mg/kg)-miltefosine (100 mg/day for 28 days) combination regimen, in Ethiopian patients. Patients with clinical improvement but without parasite clearance at day 29 received a second round of the allocated treatment. The extended treatment strategy with the combination regimen showed the highest documented efficacy in HIV-VL patients, supporting recommendation of this regimen as first-line treatment strategy for HIV-VL patients in eastern Africa.

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Drugs for Neglected Diseases initiative (DNDi) is a collaborative, patients’ needs-driven, non-profit drug research and development (R&D) organization that is developing new treatments for neglected patients.

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